| CTRI Number |
CTRI/2025/05/087643 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the result of Gomutra haritaki churna and kanchanar churna along with mulakadi taila uttarbasti in Garbhashaya Arbuda. |
|
Scientific Title of Study
|
Randomised Comparative Clinical Study to Evaluate the Efficacy of Gomutra Haritki Churna and Kanchnar Churna along with Mulakadi Taila Uttara Basti on Garbhashaya Arbuda W.S.R to Uterine Fibroid |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritasha Dubey |
| Designation |
M.S. Scholar |
| Affiliation |
Mohan Malviya Government Ayurved College Ambamata Udaipur |
| Address |
P G Department of Prasuti Tantra Evum Striroga Madan Mohan Malviya Government Ayurved College Ambamata Udaipur
Udaipur
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
6376050230 |
| Fax |
|
| Email |
dr.ritasha.dubey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor & HOD And Guide |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Ambamata Udaipur |
| Address |
P G Department of Prasuti Tantra Evum Striroga Madan Mohan Malviya Government Ayurved College Ambamata Udaipur
Udaipur
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor & HOD And Guide |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Ambamata Udaipur |
| Address |
P G Department of Prasuti Tantra Evum Striroga Madan Mohan Malviya Government Ayurved College Ambamata Udaipur
Udaipur
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9950129673 |
| Fax |
|
| Email |
narendermeena42@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt. Ayurved College Udaipur,313001,Rajasthan India |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Govt. Ayurved College Udaipur,313001,Rajasthan India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritasha Dubey |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
O.P.D.No.-5, Prasuti Tantra Evum Stri Roga Department,Udaipur Rajasthan,
OPD No.- 6 Prasuti Tantra Evum Striroga Department ,Rajkiya Ayurved Chikitsalaya Moti Chouhatta Udaipur Rajasthan
Udaipur
RAJASTHAN |
06376050230
dr.ritasha.dubey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ISTITUTIONAL ETHICS COMMITTEE Madan Mohan Malviya Govt. Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D259||Leiomyoma of uterus, unspecified. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/, उत्तर-बस्तिः | (Procedure Reference: Bhavprakash chikitsa 44/45, Procedure details: a procedure of installation of oil through vaginal route with the help of IUI canulla) with mulkadi taila in the dose of 5 ml for 3 days for 3 consecutive cycle after cessation of menses)))
(1) Medicine Name: Mulkadi Taila, Reference: Bhavprakash chikitsa 44/45, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KANCHANAR CHURNA, Reference: Bhavprakash nighantu Guduchyadi varga /103-104, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GOMUTRA HARITAKI, Reference: Ashtang hridya chikitsa sthan 8/55&56 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 4 | Comparator Arm | Procedure | - | uttarabastikarma, उत्तरबस्तिकर्म | (Procedure Reference: Bhavprakash chikitsa 44/45, Procedure details: , Procedure details: Uttarbasti (a procedure of installation of oil through vaginal route with the help of IUI canulla) with mulkadi taila in the dose of 5 ml for 3 days for 3 consecutive cycle after cessation of menses))
(1) Medicine Name: Mulkadi Taila, Reference: Bhavprakash chikitsa 44/45,, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient who are willing for trial
2.Single or multiple uterine fibroid
3.The patient either asymptomatic or having clinical sign and symptoms of fibroid.
|
|
| ExclusionCriteria |
| Details |
1.Patient having bleeding due to abortion or any other pathological condition
2.Patients having coagulation disorders.
3.Patient of age less than 30 years and above 50 years
4.Pregnant women
5.Anemic patient whose hemoglobin is below 7 gm.%
6.Patient having any systemic disease like uncontrolled hypertension, diabetes mellitus
7.Patient using IUCDs
8.Having any kind of malignancy.
9.Patient with positive VDRL, HIV, HbsAg,
10.Patients who are contraindicated for Uttar Basti.
11.Large size uterine fibroid with severe menorrhagia and severe pressure symptoms
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of trial drug and procedure to Change in the size and volume of uterine fibroid |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of trial drug and procedure on clinical features of the Garbhashaya Arbuda |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The most common benign tumour of the uterus is the uterine fibroid. Despite not being malignant, it can have a negative impact on women’s overall health and quality of life. Among women over 30 years the disease has a 20% prevalence These are more prevalent in nulliparous couples or infertile individuals with one kid. Gynaecologist often deal with uterine fibroids in their daily practice. Oral medication, hormonal therapy, hysterectomy, and other therapeutic techniques are used to treat uterine fibroids, but they are less effective, and patients find it difficult to accept hysterectomy .Due to Modern science limitation, Ayurveda has great scope in the field to find out effective and invasive approach to manage the disease and improve the quality of life This Study is about to Randomized Comparative Clinical Study to Evaluate the Efficacy of Gomutra Haritaki Churna and Kanchanar Churna along with Mulakadi taila Uttara basti on Garbhashaya Arbuda W.S.R. to Uterine Fibroid There will be Two Group of 30 Patient. Group A Patient will be treated with Gomutra Haritaki Churna 3 gm BD and 5 ml mulkadi Taila Uttarbasti Basti (per vaginal) for 3 days for 3 consecutive menstrual cycle. while other 30 patients of group B will be treated with 3 gm BD kanchanar churna and 5 ml mulkadi Taila uttara Basti (per vaginal for 3 days for 3 consecutive menstrual cycle. This trial study will be carried out for 3 months (90 days) & the follow up of the case will be after every 15 days. Final assessment will be done after completion of 3 months of treatment course on the basis of subjective, objective assessment and laboratory investigations.The data will be analyzed scientifically and statistically. |